China will begin compulsory testing on every batch of blood
products from January 1, 2008, as one of its latest moves to
tighten supervision of blood and biological products, according to
the State Food and Drug Administration (SFDA).
"Every batch of blood products must pass the compulsory test
before being put on the market or being imported," said SFDA
spokeswoman Yan Jiangying Tuesday.
The blood samples will tested by the National Institute for the
Control of Pharmaceutical and Biological Products (NICPBP) in
Beijing.
"In the future, samples from every batch of blood products will
be sent to the NICPBP before sale or import," Yan said, noting "it
will take longer to approve the blood products production and sale
but it is worthwhile since people's life safety can be better
protected with stricter supervision."
China has strengthened supervision of pharmaceutical and
biological products this year. In July, the SFDA revoked the
production license of Guangdong Baiyi Pharmaceutical Company after
it made a blood product from an infected donor. The antibodies of
some patients injected with the blood tested positive for hepatitis
C.
In the past, only part of blood and biological products are
required to take the compulsory test, according to Yan.
Since the end of 2002, China has adopted state compulsory test
for every batch of human albumin; Since January, 2006, China has
applied the compulsory test for all vaccine products used for
disease prevention; Since June, 2007, China has required all human
immumoglobulin to take the compulsory test.
Yan said from next year, the compulsory test will be expanded to
all blood products, all vaccine used for disease prevention and
most biological products.
Besides the test, another important measure taken by the Chinese
government is to set quarantine period for blood plasma used as the
materials for blood products next year.
"All the blood plasma used to make blood product must pass test
90 days after blood plasma is collected," Yan Jiangying,
spokeswoman of the State Food and Drug Administration.
"From July 1, 2008, only the blood plasma, tested qualified
after the 90 days' quarantine period, can be made into blood
product," Yan stressed.
"There was no such quarantine period in China and we hope this
new measure can help us to root out possible virus contained in the
blood such as HIV," she said.
In addition, SFDA will continue to send inspectors to China's 33
blood products manufacturers and 33 vaccine manufacturers to
strengthen supervision of the quality of blood and biological
products.
Since March 31, SFDA has began to sent inspectors to the 66
manufacturers to strengthen supervision of blood and biological
products.
(Xinhua News Agency September 12, 2007)